How Do Medical Affairs and Regulatory Affairs Professionals Co-Create The Regulatory Strategy From The Beginning?

New ways clinical trials and real-world studies will be conducted and how should MA and RA professionals prepare for that

How are the regulatory expectations in emerging markets evolving?

The regulatory process in emerging markets is getting more streamlined & structured. There is a substantial increase in the use of digital portals for application, review, approval and tracking.
Regulators in emerging markets are also becoming more keen to understand the real-world implications, effectiveness and safety of the drugs. The importance and emphasis on real-world evidence and analytics are increasing.

What are the evolving areas where Medical Affairs and Regulatory Affairs professionals can collaborate in emerging markets?

With real-world evidence given more emphasis in the industry, regulators and by clinicians, it is expected that there will be more real-world studies to be conducted in the days to come. Medical Affairs and Regulatory Affairs professionals can co-create the regulatory strategy from the beginning. Regulatory Affairs can be involved in the process from the conceptual and design stage of the study. To overcome the perceived limitations of real-world studies, the inputs from Regulatory Affairs to ensure smooth regulatory approval will be important.

What are the new skill sets required for Medical Affairs and Regulatory Affairs professionals?

The way in which clinical trials and real-world studies will be conducted is expected to undergo a radical transformation. AI, machine learning and such technologies are expected to play a critical role in the conduct of the studies reducing the time and resources. However, the understanding of how these technologies work and what are the potential biases/ drawbacks is limited. A deeper understanding is required to make optimal use of these technologies so that the studies are robust in design, conduct, analysis and interpretation. In view of this, Medical Affairs and Regulatory Affairs professionals should equip themselves to understand these technologies, their advantages and their limitations.

Romik Ghosh is a Director Medical Affairs at Novo Nordisk. He leads the Medical Affairs team at Novo Nordisk India – one of the largest in the pharmaceutical industry. Romik has 15+ years of industry experience across various therapeutic areas like Diabetes, Cardiovascular, Obesity, Rare Diseases, etc. He led 30+ clinical trials – phase 2, 3, 4, registries and real-world studies, including some of the largest and first-of-its-kind real-world studies on diabetes in India. He has 30+ publications in reputed international journals & posters at international congresses and is a recipient of various prestigious awards, including Governor’s Excellence Award from Governor of West Bengal, the AIOCD AWACS Award for brand excellence, Frost & Sullivan Award for portfolio excellence. Romik is an avid traveller, plays cricket, historophile, movie buff.